In this comparative open-label cohort study, the investigators compared the efficacy and safety of tacrolimus (TAC)and cyclophosphamide (CYC) in the treatment of diffuse proliferative and membranous lupus nephritis with severe renal disease. Treatment of lupus nephritis (LN) with cyclophosphamide is effective, but retain a certain proportion of renal function exacerbations. Tacrolimus may be a suitable substitute treatment for CYC.

Methods: Forty patients with diffuse proliferative or membranous were recruited for this trial, 45% of them had lower Ccr (<60mL/min/1.73m2), 10% had increased serum creatinine (>180µmol/L) and 67.5% had nephritic proteinuria (>3.5g/day). The investigators compared the efficacy and adverse effects of TAC (0.04-0.08 mg/kg/d) and prednisone for 12 months (TAC group) with pulse cyclophosphamide (750mg/m2 per month for six months) and prednisone followed by azathioprine (50mg/day）for 6 months (CYC group).

The secondary outcome measure were time required for CR, cumulative rate of sustained remission, relapse rate, immunological parameters, side effects, renal function during treatment and followed-up, and compliance with therapy and TAC dosing and serum levels.

previous treatment with cyclosporine, mycophenolate mofetil treatment for at least two weeks in the previous three months

known allergies to calcineurin inhibitors

severe infection or illness

symptoms of a central nervous system disorder

alanine aminotransferase more than 100U/L

evidence of active hepatitis

fasting blood glucose more than 6.2 mmol/L

2 h post-meal blood glucose more than 11.1mmol/L

Contacts and Locations

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For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01207297

Sponsors and Collaborators

Zhejiang University

Investigators

Principal Investigator:

Jianghua Chen, MD

The First Affiliated Hospital, College of Medicine, Zhejiang University